1. Field of the Invention
This invention relates to aqueous anti-inflammatory steroid formulations suitable for nasal administration, and to methods for treating inflammation of the nasal mucosa by intranasal administration of said formulations.
2. Related Disclosure
Acceptable formulations must be able to dissolve or suspend an active compound without precipitation or undue oxidation of the components. In other words, acceptable formulations must be stable. Acceptable formulations must also avoid creating discomfort upon administration, and will employ only pharmaceutically acceptable components. Finally, acceptable formulations must not support the growth of microorganisms, and so generally include preservatives.
Anti-inflammatory steroids are difficult to formulate in aqueous solutions due to their generally low solubility in water. Aqueous formulations of anti-inflammatory steroids such as flunisolide suitable for nasal administration are commercially available, for example under the trademark Nasalide.RTM.. However, currently available formulations, while safe and effective, are known to cause stinging upon administration in some cases, which is a side effect particularly undesirable when treating nasal inflammation. The novel formulations of the invention are stable, effectively preservable, and are suitable for nasal administration of anti-inflammatory steroids without causing stinging.